REGENT,STANDARD,MASTERS MECHANICAL HEART VALVES
FDA premarket approval P810002/S093 · decided 2015-02-10
Approval details
- PMA number
- P810002
- Supplement
- S093
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REGENT,STANDARD,MASTERS MECHANICAL HEART VALVES
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- ABBOTT MEDICAL
- Date received
- 2015-01-12
- Decision date
- 2015-02-10
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- IMPLEMENTATION OF NEW EQUIPMENT FOR SILICON WEIGHT PERCENT MEASUREMENT OF THE ORIFICE AND LEAFLET COMPONENTS OF SJM MECHANICAL HEART VALVES.
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